TRIDENT ANCHOR

• K Number: K060914
• Device Name: TRIDENT ANCHOR
• Manufacturer: JOHNSON & JOHNSON COMPANY
• Date Cleared: 2006-06-09 ( 66 days)
• Product Code: HWC , MBI
• Regulation Number: 888.3040
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K970089 , K971922 , K051219 , K042914
• Predicate For: K063478 , K100532

Intended Use

Trident Anchor is indicated for use in the following:
Shoulder: Rotator Cuff Repair, Biceps Tenodesis
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament
Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;
Joint Capsule Closure
Elbow: Biceps Tendon Reattachment

Device Description

The Trident Anchor System includes the Trident Anchor, which will be
presented sterile, pre-mounted on an inserter shaft w/anvil with or
without a threader tab and suture. The System will be deployed with
the use of a reusable Deployment Gun. The Anchor could be provided
with a variety of #2 suture options.

AI/ML Overview

The provided text is a 510(k) summary for the Trident Anchor, a medical device. This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, thereby not requiring a Premarket Approval (PMA) application.

A 510(k) summary does not typically contain detailed information about specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies in the way you've outlined for an AI/ML device. Instead, it focuses on demonstrating equivalence through:

• Indications for Use: Showing similar intended applications.
• Technological Characteristics: Comparing design, materials, and operating principles.
• Performance Data: Presenting results from various tests (e.g., mechanical, biocompatibility, sterilization) to show the device performs as intended and is equivalent to the predicate, but not usually in the context of an AI/ML model's diagnostic accuracy.

Therefore, many of the specific questions you asked cannot be answered directly from the provided text, as they pertain to the validation of an AI/ML system, which is a different regulatory pathway.

Here's an attempt to extract what is available and explain why other information is not present:

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Acceptance Criteria and Device Performance

Acceptance Criteria (Inferred from 510(k) context)	Reported Device Performance (as stated in the 510(k) summary)
Substantial Equivalence: To predicate devices regarding indications for use, technological characteristics, and safety and performance.	"Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices."
Biocompatibility: Device materials must be safe for human contact.	(Implied by "safety and performance testing" and comparison to predicate devices, but specific results are not detailed in this summary.)
Mechanical Performance: The anchor must meet specific physical and mechanical requirements (e.g., strength, fixation).	(Implied by "performance and safety testing" and comparison to predicate devices, but specific results are not detailed in this summary.)
Sterilization: The device must be provided sterile.	"The Trident Anchor System includes the Trident Anchor, which will be presented sterile..."

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Study Details (Based on the provided 510(k) summary)

1. Sample size used for the test set and the data provenance:

   • Not Applicable / Not Provided: This 510(k) is for a physical medical device (bone anchor), not an AI/ML diagnostic system. The "test set" in the context of a 510(k) for a physical device refers to various engineering and biological tests (e.g., mechanical strength, biocompatibility, sterilization), not a dataset of medical images or patient records for algorithmic evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable / Not Provided: Ground truth, in the context of expert consensus on medical data, is not relevant for the regulatory submission of a physical bone anchor. Safety and performance are established through laboratory testing and predicate device comparison.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable / Not Provided: This relates to expert review of medical data for AI/ML validation, which is not part of this 510(k) submission.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not Applicable / Not Provided: MRMC studies are specific to evaluating diagnostic devices, particularly those involving human readers (e.g., radiologists) and potentially AI assistance. The Trident Anchor is a surgical implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not Applicable / Not Provided: This question is relevant for AI/ML algorithms. The Trident Anchor is a physical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable / Not Provided: For a physical device like a bone anchor, "ground truth" would be established through engineering specifications, material properties, and in vitro/in vivo biomechanical testing, rather than expert consensus on diagnostic images or pathology.

7. The sample size for the training set:

   • Not Applicable / Not Provided: There is no "training set" in the context of a 510(k) for a physical device. This refers to data used to train an AI/ML model.

8. How the ground truth for the training set was established:

   • Not Applicable / Not Provided: See above; this is not relevant for a physical medical device submission.

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Summary of what is available from the document:

• The device is called the "Trident Anchor."
• It's a "Fastener, Fixation, Nondegradable, Soft Tissue Smooth or threaded metallic bone fixation fastener."
• It's indicated for various orthopedic repairs in the shoulder, knee, and elbow (e.g., Rotator Cuff Repair, Ligament Repair).
• It is considered "substantially equivalent" to predicate devices (ROC EZ Fastener, Arthrex Pushlock Anchor, ArthroCare Opus Magnum Implant) based on indications for use, technological characteristics, and safety and performance testing.
• The device will be presented sterile and pre-mounted on an inserter.

The document does not contain the specific performance metrics, study designs, or data provenance relevant to an AI/ML device validation, as it is for a traditional surgical implant.

Summary

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K060914 Page 1 of 2

SECTION 2 – 510(k) SUMMARY

	Trident Anchor		JUN - 9 2006
Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company325 Paramount DriveRaynham, MA 02767Telephone:[phone]Facsimile:508-828-3750e-mail:	[e-mail]
Name of Medical Device	Classification Name:	Fastener, Fixation, Nondegradable, SoftTissue Smooth or threaded metallic bonefixation fasteners
	Common/Usual Name:Proprietary Name:	Bone AnchorTrident Anchor
Substantial Equivalence	Trident Anchor is substantially equivalent to:ROC EZ Fastener (K970089 & K971922); the Arthrex PushlockAnchor (K051219) and the ArthroCare Opus Magnum Implant(K042914).
Device Classification	This device carries an FDA product code MBI and HWC, and isclassified as Fastener, Fixation, Nondegradable, Soft Tissue Smooth orthreaded metallic bone fixation fasteners under 21 CFR 888.3040.
Device Description	The Trident Anchor System includes the Trident Anchor, which will bepresented sterile, pre-mounted on an inserter shaft w/anvil with orwithout a threader tab and suture. The System will be deployed withthe use of a reusable Deployment Gun. The Anchor could be providedwith a variety of #2 suture options.
Premarket Notification: Traditional			Confidential

Premarket Notification: Traditional Trident Anchor

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Indications for Use	Trident Anchor is indicated for use in the following:Shoulder: Rotator Cuff Repair, Biceps TenodesisKnee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis;Joint Capsule ClosureElbow: Biceps Tendon Reattachment
Safety and Performance	Results of performance and safety testing have demonstrated that themodified device is substantially equivalent to the predicate devices.Based on the indications for use, technological characteristics, andcomparison to predicate devices, the Trident Anchor has been shown tobe substantially equivalent to predicate devices under the Federal Food,Drug and Cosmetic Act.

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Confidential

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2006

DePuy Mitek a Johnson & Johnson Co. % Ms. Ruth C. Forstadt Project Management Lead, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K060914

Trade/Device Name: Trident Anchor Regulation Code: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulation Class: II Product Code: HWC, MBI Dated: April 3, 2006 Received: April 4, 2006

Dear Ms. Forstadt:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 -- Ms. Ruth C. Forstadt

CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page Of

510(k) Number (if known): K660914

Device Name: Trident Anchor

Trident Anchor is indicated for use in the following:

Shoulder: Rotor Cuff Repair, Biceps Tenodesis Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Joint Capsule Closure Elbow: Biceps Tendon Reattachment

Prescription Use

OR

Over-the -Counter Use No
(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

Division Sign-Off) Division of General, Restorative and Neurological Devices

Number K06 09/4

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.